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FDA 510(k)

STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM

K-Number: K112593 · 2012-05-01

ApplicantStryker Corporation
Decision Date2012-05-01
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2012-05-01 under 510(k) number K112593. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM is a medical device that received FDA 510(k) clearance on 2012-05-01. The listed applicant is Stryker Corporation. The 510(k) number is K112593.

When did STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM receive FDA 510(k) clearance?

STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM received FDA 510(k) clearance on 2012-05-01, under 510(k) number K112593.

Who is the listed applicant for STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

The FDA 510(k) record lists Stryker Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM?

The FDA product code for STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM is ERL.

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Related Devices (Code: ERL)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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